Biomedical Engineering Reference
In-Depth Information
uncertainty for researchers, politicians and communities, they have
also created strategic opportunities for governments keen on
developing this field of research as part of a deliberate approach to
targeting developments in the global knowledge economies.
The complexity of gaining approval to conduct a clinical trial
involving hESC-derived cells is one of the biggest barriers to ongoing
development in the field. Should the current clinical trials continue
without any adverse events, then it might be expected that further
products will start to enter Phase I trials. Moreover, with increasing
expertise in the regulation and monitoring of clinical trial development
at the FDA, the approval process should become less complex and
more straightforward over time. As more clinical products start to
move through the regulatory approval process, the FDA will be able
to develop standard assessment protocols for hESC-derived therapies.
Increasing expertise over time on behalf of regulators can only help
developers negotiate the regulatory process.
The outcomes of the current clinical trials will have a major
impact on the progress of hESC-based research. If any of the patients
in the Geron or Advanced Cell Technology trials report any kind of
improvement in their different conditions - and, importantly, no
adverse reactions - the pressure from patients, their carers and
advocates to continue to develop hESC-derived treatments can be
expected to escalate significantly. Patient demand for hESC-based
therapies will be the single biggest driver of market expectations,
and increased demand can only have a positive incentivizing effect
on companies looking at bringing products to market.
Overall, then, the political and social environment is just as
important as the clinical setting. In some respects, while the clinical
success of hESC research will represent a major development on the
part of contemporary biomedicine, outside of no adverse events
happening in the current trials the most important developmental
milestone for hESC research will lie in resolving some of the social
and political issues that continue to threaten its ongoing development.
For the moment, attention is primarily focused on the issue of public
funding and the resolution of patenting disputes. Adequate outcomes
of these particular points will leave a clear path for the commercial
future of hESC research.
